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FDA 510(k)

Breo Laser Hair Growth Comb (Scalp 3L)

N.º K: K242620 · 2024-11-01

SolicitanteShenzhen Breo Technology Co., Ltd.
Fecha de decisión2024-11-01
Código de productoOAP
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Breo Laser Hair Growth Comb (Scalp 3L) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Breo Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K242620. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Breo Laser Hair Growth Comb (Scalp 3L)?

Breo Laser Hair Growth Comb (Scalp 3L) is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Shenzhen Breo Technology Co., Ltd.. The 510(k) number is K242620.

When did Breo Laser Hair Growth Comb (Scalp 3L) receive FDA 510(k) clearance?

Breo Laser Hair Growth Comb (Scalp 3L) received FDA 510(k) clearance on 2024-11-01, under 510(k) number K242620.

Who is the listed applicant for Breo Laser Hair Growth Comb (Scalp 3L)?

The FDA 510(k) record lists Shenzhen Breo Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Breo Laser Hair Growth Comb (Scalp 3L)?

The FDA product code for Breo Laser Hair Growth Comb (Scalp 3L) is OAP.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: OAP)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262183Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)Shenzhen Nuon Medical Equipment Co., Ltd.K262254Hair Growth Comb (X-GC01)Guangdong Ashmore Health Technology Co., Ltd.K261675CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)Shenzhen Chuanghong Zhilian Technology Co., Ltd.K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)Ziree Co., Ltd.K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)Hubei Yjt Technology Co.,LtdK260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)Zdeer Technology (Henan) Co., Ltd.

Fuente oficial

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